Non-invasive method for slimming a human body using laser energy of wavelengths shorter than 632 nm

ABSTRACT

A noninvasive method of slimming a patient&#39;s body by applying laser energy having a wavelength shorter than 632 nm externally through the skin of the patient. One or more areas of a patient&#39;s body, preferably the more fatty regions, such as the abdominal, buttock, lower back, thigh, bust or arm regions, is measured. Objective measurements are made of body criteria, including external dimension, percentage body fat, fat mass, or body mass. Sufficient laser energy, preferably in a range of 0.03-0.1 J/cm 2 , is applied to one or more of those areas to cause a reduction in the measurement in the lasered areas, as well as overall body slimming. The preferred embodiments use laser light at about 532 nm, 440 nm, or 405 nm. Preferably 18 mW or 25 mW laser diodes are used to apply laser energy at 0.03-0.1 J/cm 2  for 15 minutes, every other day for 1-4 weeks, depending on the amount of slimming desired.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of co-pending, U.S. patentapplication Ser. No. 11/053,369 filed Feb. 7, 2005, which claims thebenefit of U.S. Provisional Application No. 60/542,720 filed Feb. 6,2004, now expired. This application is a continuation of co-pending U.S.patent application Ser. No. 13/785,346 filed Mar. 5, 2013. applicationSer. No. 11/053,369, 60/542,720 and Ser. No. 13/785,346 are incorporatedby reference in their entirety.

FIELD OF INVENTION

This invention relates to a method for non-invasive, non-destructiveshaping and contouring of a human body by external means. In particular,this invention relates to the application of laser energy withwavelengths shorter than 632 nm to targeted external regions of apatient's body to slim the patient's body.

BACKGROUND

There is a great demand to be slimmer. The tired and true method oftaking in fewer calories than a person expends results in weight loss,and the resultant slimming effect occurs over the body as a whole. Formore targeted contouring, many people resort to the cosmetic surgicalprocedure known as liposuction, wherein excess adipose tissue, alsoknown as fat, is suctioned from the body of a patient. The typicalpurpose of the liposuction procedure is to leave the patient thinner indesired areas, with aesthetically more appealing body contours. Forexample, liposuction is often performed on patients to remove excess fatin the abdominal, buttock, thigh, breast or arm regions of the body.

Liposuction is performed by inserting a narrow tube, or cannula, througha tiny incision in the skin into the subcutaneous fatty tissue. Thecannula is repeatedly pushed then pulled through the fat layer,separating and puncturing the fat cells and suctioning them out. Suctionaction through the cannula is provided by a vacuum pump or a largesyringe. The procedure carries with it some risks and side effects. Dueto the physical damage induced, the procedure can damage nerves,lymphatics and vasculature in the surrounding area, often resulting insignificant loss of blood as the blood is vacuumed out with the fat andthe formation of seroma due to damaged lymphatic channels. In addition,the post-procedure recovery period is long and often accompanied by agreat deal of inflammation, bruising and concomitant pain.

Since the liposuction technique was first developed there have been manyimprovements to techniques for contouring the body, with the goal ofmaking the surgery less dangerous for the patient, reducing the negativeaspects of the post-operative recovery period, and making it morecommercially viable for the practitioner who treats the patient.

Non-invasive methods of body contouring are preferred over invasivemethods to minimize trauma to the patient, reduce the risk of infection,and speed up recovery time, among other reasons. To avoid invasiveprocedures, electromagnetic energy, such as microwave, ultrasound orradio frequency radiation, has been used to reduce fat. In U.S. Pat. No.5,507,790 issued to Weiss, a method is described in which a medicamentis applied to a patient's skin where fat removal is desired and focusedelectromagnetic energy is applied to the same work site to heat thefatty tissue and increase fat lipolysis. In U.S. Pat. No. 5,143,063,Fellner takes this method even farther, applying sufficientelectromagnetic radiation to destroy the fat cells. Yet another methodis to inject an intumescing solution below the skin and applyelectromagnetic energy externally to the body. These procedures aredisadvantageous in that they utilize such high energy sources that theyexcessively heat the surrounding tissue, which can result in damage tothe tissue and pain. Again, recovery time is significant.

In a recent innovation, a procedure was developed by a group includingone of the inventors of this method which uses red LLLT alone, tocontour the body by reducing fat. The procedure is described in U.S. PatPub. 2005/0203594 and involves using a device having lasers of less than1 W to apply one or more treatments of 635 nm laser energy externally tothe patient to release at least a portion of the intracellular fat intothe interstitial space. Upon sufficient doses of this low-level laserenergy at 635 nm, the cell membrane was thought to be momentarilydisrupted, releasing the intracellular fat into the interstitial space.Upon cessation of the energy application, the pores closed and the cellmembrane returned to contiguity. The treated and surrounding tissue wasnot heated and not damaged, and the patient felt no sensation during theapplication of the 635 nm laser energy. The released fat was removedfrom the patient's body through one or more of the patient's normalbodily systems. This method revolutionized the market for bodycontouring because it reduced fat with no trauma to the patient.

The LLLT industry heretofore believed that using lasers with wavelengthsshorter than about 632 nm would fail to non-traumatically shape apatient's body. One reason is that it is believed that the shorterwavelengths would not penetrate the skin deep enough to reach the fatcells and other tissues needed to attain shaping. For example, U.S. Pat.No 7,771,374 issued to Slatkine, discloses that melanin and blood in theskin do not allow light at 405 nm, 514 nm or 585 nm to penetrate deepinto the skin due to strong absorption. Instead, the patent disclosesusing a vacuum to expel blood from the treatment area to improvetreatment of the tissue.

Lasers emit electromagnetic energy, which can be described by frequency,wavelength, or energy. Laser diodes with shorter wavelengths have ahigher energy than laser diodes with longer wavelengths. Another reasonthat it was believed that the shorter wavelengths would fail tonon-traumatically reduce fat was because in order to penetrate the skinto a deep-enough depth, the higher-energy wavelengths would heat thesurrounding tissue through which the laser penetrated, traumatizing thepatient. Laser devices emitting wavelengths shorter than about 632 nmlasers are known in the art, but only for ablative treatments. To coolthe radiated skin and minimize trauma to the patient, complicatedcooling components were invented to reduce the heat generated by theshorter wavelength therapeutic lasers. For example, in U.S. Pat. Pub2008/0294153, Altshuler describes a cooling system for a green laserlight used as a thermal treatment to remove a red portion of a tattoo bycausing the death of the cells containing the tattoo ink particles byrupture or apoptosis.

Yet another reason that it was believed that the shorter wavelengthswould fail to non-traumatically shape a targeted area of the body isthat any wavelength other than about 635 nm would be ineffective forstimulating the cell to open the transitory pore to release fat.Consequently, only devices emitting red laser energy have been used forshaping the body.

While the red LLLT is effective in reducing fat, patients and doctorshave clamored for a non-invasive method of slimming that takes lesstreatment time. It would be desirable to capitalize on the higher energyof shorter wavelengths to do so in less time than prior art methods,without traumatizing the tissue. Therefore, an object of this inventionis to provide a non-invasive method of reducing the circumference ofdesired areas of a human body in less time than prior art methods.Another object is to provide a non-invasive method of reducing thecircumference desired areas of a human body in less time than prior artmethods, which does not destroy fat cells or otherwise damagesurrounding tissue or structures. It is another object of the method toslim the patient's body as a whole. It is another object to provide anon-invasive method of slimming a human body using lasers emittingwavelengths shorter than 632 nm.

SUMMARY OF THE INVENTION

This invention is a noninvasive method of slimming a patient's body byapplying laser energy having a wavelength shorter than 632 nm externallythrough the skin of the patient. One or more areas of a patient's body,preferably the more fatty regions, such as the abdominal, buttock, lowerback, thigh, bust or arm regions, is measured. Objective measurementsare made of body criteria, including circumference, percentage body fat,fat mass, or body mass. Sufficient laser energy, preferably in a rangeof 0.03-0.1 J/cm², is applied to one or more of those areas to cause areduction in the measurement in the lasered areas, as well as overallbody slimming. The preferred embodiments use laser light at about 532nm, 440 nm, or 405 nm. Preferably 18 mW or 25 mW laser diodes are usedto apply laser energy at 0.03-0.1 J/cm² for 15 minutes, every other dayfor 1-4 weeks, depending on the amount of slimming desired.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 Schematic illustration of application of low-level laserradiation.

FIG. 2 Flow diagram of present method.

FIG. 3 Flow diagram of alternate embodiment of present method.

DETAILED DESCRIPTION OF THE INVENTION

Lasers emit electromagnetic energy, which can be described by frequency,wavelength, or energy. Laser diodes with shorter wavelengths have ahigher energy than laser diodes with longer wavelengths. See Table 1:

% difference Wavelength (nm) Energy (eV) over 635 nm 635 (red) 1.82 —532 (green) 2.24 23% 440 (violet) 2.84 56% 405 (violet) 3.09 68%

Despite heretofore long-recognized reasons that using wavelengthsshorter than 635 nm to treat patients would be ineffective—or worse,dangerous—the present invention is a method for slimming a patient'sbody non-traumatically by using shorter wavelengths, preferably green orviolet laser light. The present invention uses green or violet laserlight instead of red laser light with the surprising result ofnon-traumatically slimming a patient in far less time than red laserlight would have taken. In general, using green laser light instead ofred laser light decreases the time of treatment by 25% and also resultsin 25% more fat reduction across the treated area.

In the method's simplest form, a patient's body is measured initially,laser therapy is applied to the patient, and the measurement is repeatedshortly after laser treatment to determine whether the measurement isreduced. See FIGS. 1-3. If so, no more laser therapy is applied. If not,more laser therapy is applied until the measurement is reduced.Preferably the same person makes the same measurement before and aftertreatment, with the same measuring tool, so that measurement variationsdue to different people and tools are minimized. More specifically,after measurement sufficient laser energy is applied to one or more ofareas to cause a reduction in the measurement in the lasered areas. Thepreferred embodiments use laser light at about 532 nm, 440 nm, or 405 nmwith 18 mW or 25 mW laser diodes, applied for 15 minutes, resulting inthe application of laser energy at 0.03-0.1 J/cm². Treatments arerepeated, preferably every other day for 1-4 weeks, depending on theamount of slimming desired.

Measurements are made using objective, non-invasive modes to determinethe patient's external dimensions, fat mass, or body mass (weight). Tapemeasures, as exemplified above, are typically used to measurecircumference. DEXA, or dual energy x-ray absorptiometry, can be used todetermine body fat percentage, fat mass, bone mass and lean massseparately for the arms, trunk, and legs. Ultrasound or magneticresonance imaging (“MRI”) can also be used to measure body fatpercentage. Scales can be used to measure weight, hydrostatically or outof the water. Combinations of these measurement modes can be usedtogether to better quantify the slimming.

Using external dimension as the measurement mode in a first example, aninitial measurement is made of the circumference of one or more areas ofa patient's body, preferably the more fatty regions, such as theabdominal, buttock, lower back, thigh, breast or arm regions. Forexample, a tape measure is used to measure the circumference of thepatient's torso at the navel. As illustrated in FIG. 1, laser energy 12of a wavelength less than about 632 nm is applied to the patient 10 atand around the navel. Sufficient laser energy is applied to the patientto cause the torso measurement to be reduced, typically about 0.03-0.1J/cm². The area treated is roughly about 200 cm²-450 cm² area, or abouta 6″×6″ to about an 8″×8″ square.

A second measurement is taken shortly, preferably within 2 minutes,after the laser treatment to measure the circumference of the patientaround the same area of the torso, namely at the navel. If the secondmeasurement is less than the initial measurement then no more lasertreatments are made. If, however, the second measurement is not lessthan the initial measurement, more laser energy of a wavelength lessthan about 632 nm is applied to the patient at and around the navel,again about 0.03-0.1 J/cm². A third measurement is taken shortly afterthe second laser treatment to measure the circumference of the patient'storso at the navel. If the third measurement is less than the initialmeasurement of the circumference of the patient's torso at the navel,then no more laser treatments are made. If the third measurement is notless than the initial measurement, the process is repeated until themeasurement is less than the initial measurement.

Preferably additional measurements are made before and after treatmentin other regions of a patient's body, such as the neck, buttock, lowerback, thigh, bust, calf, knee, wrist, ankle, or upper arm. Thesemeasurements show the slimming effect in areas other than the treatedareas and can be used to determine the amount of laser energy applied.Again using external dimensions for example, a tape measure is used tomeasure the circumference of the patient's torso at the navel and thecircumference of the patient's neck, collectively referred to as theinitial set of measurements. Laser energy of a wavelength less thanabout 632 nm is applied to the patient at and around the navel.Sufficient laser energy is applied to the patient to cause the torsomeasurement to be reduced, typically about 0.03-0.1 J/cm². A second setof measurements is taken again shortly after the laser treatment, aroundthe patient's torso at and around the patient's neck. If both the secondmeasurement of the patient's torso and the second measurement of thepatient's neck are less than those measurements in the initial set ofmeasurements, then no more laser treatments are made. If, however, oneor both of the second measurements of the torso and neck is not lessthan the initial measurement of the torso and neck, more laser energy ofa wavelength less than about 632 nm is applied to the patient at andaround the navel, again about 0.03-0.1 J/cm². A third set ofmeasurements is taken shortly after the second application of lasertreatment and if both the third measurement of the patient's torso andthe third measurement of the patient's neck are less than the initialset of measurements then no more laser treatments are made. If the thirdset of measurements is not less than the initial set of measurements,the process can be repeated until the torso and neck measurements areless than when first measured. In this manner, treatment with sufficientlaser energy applied to one area causes size reduction in the laseredareas, as well as in other areas that were not treated, resulting inoverall body slimming.

In yet another embodiment, a patient is treated with laser energy in twoareas and overall body slimming is seen. Using the percentage body fat,DEXA is used to measure the patient's initial percentage body fat.Measurements may also be taken of the circumference of the patient'sneck and each of the patient's thighs using a tape measure. Laser energyof a wavelength less than about 632 nm is applied to the patient on boththighs and both hips. Sufficient laser energy is applied to the patientto cause the percentage body fat to be reduced, typically about 0.03-0.1J/cm². A second set of measurements is taken again shortly after thelaser treatment, using DEXA to measure the patient's percentage body fatand a tape measure to measure the circumference around the patient'sneck and each of the patient's thighs. If the second measurement of thepatient's body fat percentage is less than the initial measurement thenoverall slimming is achieved and no more laser treatments need to bemade. If, however, the body fat percentage is less than initiallymeasured but the external dimensions are not, the patient may be treatedagain with laser energy to achieve additional overall slimming. In thatcase, a third set of measurements is taken shortly after the secondapplication of laser treatment and if the patient's external dimensionsare less than the initial set of measurements then no more lasertreatments are made. If the third set of measurements of externaldimensions is not less than the initial set of measurements, the processcan be repeated until the thigh and neck measurements are less than whenfirst measured. In this manner, treatment with sufficient laser energyapplied to two areas causes size reduction in the lasered areas, as wellas in other areas that were not treated, resulting in overall bodyslimming.

Often patients are satisfied with the slimming results in one therapysession, however each patient may also be subjected to multiple sessionsover several weeks' time. Preferably laser energy is applied at about0.03-0.1 J/cm² for 15 minutes, every other day for 1-4 weeks, dependingon the amount of slimming desired.

Wavelengths shorter than 632 nm are used in the method described herein.The preferred embodiments use laser light at about 532 nm, 440 nm, or405 nm. A laser device that provides low-level energy is known in theart as a cold laser, such as the inventions described in U.S. Pat. No.6,013,096 issued to Tucek and U.S. Pat. No. 6,746,473, issued to Tucekand Shanks. These devices use semiconductor diode lasers which areavailable commercially in a broad range of wavelengths between 405-1500nm. The laser device may have one or more laser energy sources.Different therapy regimens require diodes of different wattages. Thepreferred laser diodes employ less than one watt of power, preferablybetween 10 mW and 50 mW, and most preferably 18 mW or 25 mW diodes. The18 mW diodes are typically used for patients with body mass index of20-30, whereas the 25 mW diodes are use for patient having BMI over 30.Diodes of various other wattages may also be employed to achieve thedesired laser energy for the given regimen.

The dosage of laser energy required to achieve slimming will varydepending on the thickness of the patient's skin, thickness of fattytissue, and other biological factors peculiar to each patient. While aperson skilled in the art will be able to determine the amount of energyneeded to slim the patient by comparing initial and subsequentmeasurements, applied energy can also be determined by the appliedfluence. Preferably a fluence of about 0.03-0.1 J/cm² is applied eachtreatment to the targeted area. The following examples are illustrative:

EXAMPLE 1

A patient's waist was measured using a tape measure. The waist measured100.9 cm in circumference. A 532 nm semiconductor diode laser withmaximum power of 18 mW was used to apply laser light to a patient's padof fat located on his belly of about 400 cm². The laser energy wasapplied for 15 minutes in a back-and-forth sweeping motion across thefat area without touching the patient, applying about 16.2 J of laserenergy. The patient's waist was measured again using the same tapemeasure. The waist measured 99.7 cm in circumference. The treatment wasrepeated again once a week for 4 more weeks. This non-invasive procedureproduced the same amount of slimming in the targeted area as would beseen with treatment using red laser light for 20 minutes every day fortwo weeks, but had an additional benefit of slimming the patient's bodyoverall. The patient suffered no pain or bruising.

EXAMPLE 2

A patient's thigh was measured using a tape measure. The thigh measured62.5 cm in circumference. A 532 nm semiconductor diode laser withmaximum power of 25 mW was used to apply laser light to an area of thepatient's thigh of about 400 cm². The laser energy was applied for 15minutes in a back-and-forth sweeping motion across the fat area withouttouching the patient, applying about 22.5 J of laser energy. Thepatient's thigh was measured again using the same tape measure. Thewaist measured 61.5 cm in circumference and showed a decrease in visiblecellulite. The treatment was repeated again every other day for 4 moreweeks. This non-invasive procedure produced the same amount of slimmingin the targeted area as would be seen with treatment using red laserlight for 20 minutes every day for two weeks. The patient suffered nopain or bruising.

EXAMPLE 3

A patient's waist and neck were measured using a tape measure. The waistmeasured 100.9 cm in circumference and the neck measured 43.2 cm. A 440nm semiconductor diode laser with maximum power of 25 mW was used toapply laser light to a patient's pad of fat located on his belly ofabout 232 cm². The laser energy was applied for 15 minutes in aback-and-forth sweeping motion across the fat area without touching thepatient, applying about 22.5 J of laser energy. The patient's waist andneck were measured again using the same tape measure. The waist measured99.7 cm in circumference and the neck 42.5 cm. The treatment wasrepeated daily for the first week and every other day for the next week.This non-invasive procedure produced the same amount of fat reduction aswould be seen with treatment using red laser light for 20 minutes everyday for two weeks. The patient suffered no pain or bruising.

EXAMPLE 4

A patient's body fat percentage was determined using a DEXA scan. Thepatient's body fat was 32.0%. A 405 nm semiconductor diode laser withmaximum power of 18 mW was used to apply laser light to a patient's padof fat located on his lower back of about 400 cm². The laser energy wasapplied for 15 minutes in a back-and-forth sweeping motion across thefat area without touching the patient, applying about 16.2 J of laserenergy. The patient's body fat percentage was re-measured using a DEXAscan and found to be 30.0%. A similar amount of laser energy was appliedevery other day for 3 more weeks. The final measurement was 28% bodyfat. This non-invasive procedure produced the same amount of fatreduction as would be seen with treatment using red laser light for 20minutes every day for two weeks. The patient suffered no pain orbruising.

While there has been illustrated and described what is at presentconsidered to be a preferred embodiment of the present invention, itwill be understood by those skilled in the art that various changes andmodifications may be made, and equivalents may be substituted forelements thereof without departing from the true scope of the invention.Therefore, it is intended that this invention not be limited to theparticular embodiment disclosed as the best mode contemplated forcarrying out the invention, but that the invention will include allembodiments falling within the scope of the appended claims. Inventor:SHANKS et al.

We claim:
 1. A method of slimming a patient, the method comprisingapplying monochromatic laser energy having a wavelength shorter than 632nm externally to the patient at a targeted area in a dose rate thatcauses no detectable temperature rise of the treated tissue.
 2. Themethod according to claim 1 wherein the laser energy is monochromaticgreen.
 3. The method according to claim 1 wherein the laser energy isabout 532 nm.
 4. The method according to claim 1 wherein the laserenergy is monochromatic violet.
 5. The method according to claim 1wherein the laser energy is about 440 nm.
 6. The method according toclaim 1 wherein the laser energy is about 405 nm.
 7. The methodaccording to claim 1 wherein applying laser energy to the targeted areaof the patient's body comprises using an 18 mW laser diode to applylaser energy at 0.03-0.1 J/cm² for 15 minutes, every other day for 1-4weeks
 8. The method according to claim 1 wherein applying laser energyto the targeted area of the patient's body comprises using an 25 mWlaser diode to apply laser energy at 0.03-0.1 J/cm² for 15 minutes,every other day for 1-4 weeks
 9. A method of slimming a patient, themethod comprising applying unfiltered laser energy externally to thepatient at a first area in a dose rate that causes no detectabletemperature rise of the treated tissue.
 10. The method according toclaim 9 wherein the laser energy is green.
 11. The method according toclaim 9 wherein the laser energy is about 532 nm.
 12. The methodaccording to claim 9 wherein the laser energy is violet.
 13. The methodaccording to claim 9 wherein the laser energy is about 440 nm.
 14. Themethod according to claim 9 wherein the laser energy is about 405 nm.15. The method according to claim 9 wherein applying laser energy to thetargeted area of the patient's body comprises using an 18 mW laser diodeto apply laser energy at 0.03-0.1 J/cm² for 15 minutes, every other dayfor 1-4 weeks
 16. The method according to claim 9 wherein applying laserenergy to the targeted area of the patient's body comprises using an 25mW laser diode to apply laser energy at 0.03-0.1 J/cm² for 15 minutes,every other day for 1-4 weeks.